Rectal Cancer PatientsLARSNCT03569488
Validation of the French Version of the Low Anterior Resection Syndrome (LARS) Among Rectal Cancer Patients
An observational study of Rectal Cancer Patients, run by University Hospital, Caen at 8 sites in France.
Trial summary
Oncological rectal cancer outcomes have improved considerably because of optimal surgery by total mesorectal excision in conjunction with multidisciplinary team management by selective multimodal therapy (ie, neo-adjuvant chemo-radiotherapy). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer Patients
- What is being tested?
- FT-LARS questionnaire
- How many people
- 1,100 participants
- Where
- 8 sitesFrance
- Study dates
- 24 Jan 2020to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: colorectal cancer
Who may be able to join
- Age between 18 and 80 years
- Rectal cancer patients undergoing curative sphincter-preserving surgery with partial or total mesorectal excision
- Surgery performed between January 2007 to January 2016, with reversal of the defunctioning stoma before January 2016;
- Hence all patients had had bowel continuity restored for at least 24 months Voluntarily participated in the study
Who cannot join
- The presence of stoma and/or known disseminated or recurrent disease
- Other diseases of bowel dysfunction (Crohn's disease)
- Cognition and/or language issues.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Chru Amiens
Amiens, 60000
jean marc regimbeau, MD,PhD, 03 22 08 88 93, regimbeau.jean-marc@chu-amiens.fr
- Recruiting
Caen University Hospital
Caen
Arnaud Alvès, MD, PhD, 0231064497, alves-a@chu-caen.fr
- Recruiting
Chru Lille
Lille, 59000
guillaume piessen, MD, PhD, 03 20 44 44 07, guillaume.piessen@chru-lille.fr
- Recruiting
Centre Oscar Lambret
Lille
Merhdad JAFARI, MD-PhD, 0320295920, m-jafari@o-lambret.fr
- Recruiting
Chru Nancy
Nancy, 57000
laurent bresler, MD, PhD, 03 83 15 31 20, l.bresler@chru-nancy.fr
- Recruiting
Chru Nantes
Nantes
guillaume meurette, MD,PhD, 02 40 08 30 41, guillaume.meurette@chu-nantes.fr
EMILIE DUCHALAIS DASSONVILLE, MD, Emilie.DASSONNEVILLE@chu-nantes.fr
- Recruiting
Chru Tours
Tours
mehdi ouaissi, MD, PhD, 02 47 47 01 87, M.OUAISSI@chu-tours.fr
- Recruiting
clc VANDEUVRE LES NANCY
Vandœuvre-lès-Nancy, 57000
frédéric marchal, MD,PhD, 03 83 59 84 51, f.marchal@nancy.unicancer.fr
About this study
Official title: Validation of the French Version of the Low Anterior Resection Syndrome (LARS) Score for Measuring Bowel Dysfunction After Sphincter-preserving Surgery Among Rectal Cancer Patients
Oncological rectal cancer outcomes have improved considerably because of optimal surgery by total mesorectal excision in conjunction with multidisciplinary team management by selective multimodal therapy (ie, neo-adjuvant chemo-radiotherapy). The 5-year survival has increased to more than 50% and local recurrence has been reduced to less than 10%. These advancements have resulted in more patient receiving sphincter-preserving surgery (SPS). With an increasing number of rectal cancer survivors, the investigators observe a rising attention to the disordered bowel function after SPS, called "low anterior resection syndrome" (LARS). LARS appear immediately after surgery, becoming most pronounced during the first few months, and improved thereafter, reaching a steady state after around two years. However, up to 60% of patients with SPS suffer from LARS which impaired their quality of life (QoL). The prevalence and severity of LARS is difficult to assess due to heterogeneity of the assessment tools. A group of Danish authors have recently developed and validated a five-item instruments for evaluation of LARS (LARS score). It represents to date the best questionnaire to capture anorectal postoperative function and consists of five items: incontinence for flatus, incontinence for liquid stool, frequency of bowel movements, clustering of stools, and urgency. It allows a categorization of patients into 3 groups: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). Developed in Danish, it is now internationally validated with translations in Chinese, English, German, Spanish and Swedish. To our knowledge, French version of the LARS score is not yet available. The aim of our study will be to adapt the LARS scale questionnaire to the French language (LARS-F), and assess its psychometric properties.
Inclusion criteria will be patients 18 years old or above who were operated for rectal cancer from 2007 to 2015. Exclusion criteria will include the presence of stoma and/or known disseminated or recurrent disease. Patients will be identified through local databases by the local investigators at each of the participating centers with a minimum duration of 24 months after surgery to allow their bowel function to have regained stability. This study will be supported by the French Research Group of Rectal Cancer Surgery in order to allow the feasibility of the project.
Read more
After translation/back-translation procedures in accordance with the permission from the original authors, the LARS-F score and the whole translation process will be then sent to the original authors for approval. Then a pilot study will be conducted. The French questionnaire (LARS-F score) will be then administered to 100 patients in order to verify the adequacy and degree of comprehension of the questions. Reproducibility will be investigated by a test-retest procedure. A randomly selected subgroup of participants (n= 400) will be sent the LARS-F score questionnaire twice (with an interval of two weeks). The test-retest reliability of the questionnaire will be assessed by the Cohen's Kappa (no, minor and major LARS scores) or by intra-class correlation coefficient, ICC (quantitative LARS score). Then, eligible patients will receive a postal invitation to complete the LARS-F score and the l'European Organization for Research and treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29, respectively. The validity of the LARS-F score will be tested by using the indicators of convergent validity and discriminant validity. The convergent validity will be determined notably in this study by computing the correlations between the LARS-F score and the EORTC QLQ-C30 and QLQ-CR29 domains. For discriminant validity testing, the investigators will use known variables to affect bowel function after SPS, such as gender, age, neo-adjuvant radiation therapy, distance of the tumor from the anal verge, prior temporary stoma, and length of postoperative period.
The validation of the French version of the LARS score will allow to use a scientific instrument in order to assess both prevalence and severity of LARS. This instrument will allow to develop a future research and clinical practice in France. It will be used in the daily clinical practice to identify patients with LARS score. It will hopefully lead to improve the awareness of clinicians, in order to improve the prevention and the treatment of bowel dysfunction, as well as the information given to patients. In the future, the investigators will able to develop a new patient-led follow-up program based on symptom burden and health-related QoL.
Read the detailed description
Inclusion Criteria:
- Age between 18 and 80 years
- Rectal cancer patients undergoing curative sphincter-preserving surgery with partial or total mesorectal excision
- Surgery performed between January 2007 to January 2016, with reversal of the defunctioning stoma before January 2016;
- Hence all patients had had bowel continuity restored for at least 24 months Voluntarily participated in the study
Exclusion Criteria:
- The presence of stoma and/or known disseminated or recurrent disease
- Other diseases of bowel dysfunction (Crohn's disease)
- Cognition and/or language issues.
Detailed description of the implemented techniques
-The validation study of the French version of the LARS score is based on one hand on the face and content validities and on the other hand on the measurement of its psychometric properties in compliance with the standards published by American Educational Research Association \& al.
Outcomes measures
- After translation/back-translation procedures in accordance with the permission from the original authors, the LARS-F score and the whole translation process will be then sent to the original authors for approval. Then, eligible patients will receive a postal invitation to complete the LARS-F score and the l'European Organization for Research and treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29, respectively. For each item, ceiling and floor effects will be sought.
- The reliability will be assessed by both internal consistency (Cronbach's alpha coefficient).
- To evaluate reproducibility, a test-retest study will be performed in a randomly selected subgroup patients by comparing LARS-F scores obtained between the patient's first and second postal invitation (in an interval of 7-14 days).
- The correlations between the LARS-F score and the EORTC QLQ-C30 and QLQ-CR29 domains will allow to determine convergent validity. For discriminant and divergent validities testing, we will hypothesize that the LARS score will differentiate between the bowel functions of patients with different demographic or clinical features such as sex, age, length of postoperative period, distance of the tumor from the anal verge, radiation therapy, and prior temporary stoma.
- Sensitivity and specificity for minor and major LARS scores will be assessed.
- Conditions
- Rectal Cancer Patients
- Being tested
- FT-LARS questionnaire
- Keywords
- quality of life, sphincter-sparing surgery, LARS score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT-LARS questionnaireDiagnostic test
FT-LARS questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
validation of the French version of the LARS score
- Cross cultural adaptation
- Reliability :
- Test-retest
- Internal consistency
- Face validity and content validity
- Floor effect - Ceiling effect
- Discriminant validity
- Convergent validity and Divergent validity
- Known-group method and relationship between each item and subscales
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start24 Jan 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, French Research Group of Rectal Cancer Surgery (GRECCAR), Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569488
- Sponsor's protocol ID
- 17-247
- Acronym
- LARS
- Status last verified
- Aug 2023
- First submitted
- 15 Jun 2018
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sarcher T, Dupont B, Alves A, Menahem B. Anterior resection syndrome: What should we tell practitioners and patients in 2018? J Visc Surg. 2018 Oct;155(5):383-391. doi: 10.1016/j.jviscsurg.2018.03.006. Epub 2018 Aug 17.
PubMed 30126800Abdelli A, Tillou X, Alves A, Menahem B. Genito-urinary sequelae after carcinological rectal resection: What to tell patients in 2017. J Visc Surg. 2017 Apr;154(2):93-104. doi: 10.1016/j.jviscsurg.2016.10.002. Epub 2017 Feb 1.
PubMed 28161008Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.
PubMed 28601342Lakkis Z, Manceau G, Bridoux V, Brouquet A, Kirzin S, Maggiori L, de Chaisemartin C, Lefevre JH, Panis Y; French Research Group of Rectal Cancer Surgery (GRECCAR) and the French National Society of Coloproctology (SNFCP). Management of rectal cancer: the 2016 French guidelines. Colorectal Dis. 2017 Feb;19(2):115-122. doi: 10.1111/codi.13550.
PubMed 27801543Pieniowski EHA, Palmer GJ, Juul T, Lagergren P, Johar A, Emmertsen KJ, Nordenvall C, Abraham-Nordling M. Low Anterior Resection Syndrome and Quality of Life After Sphincter-Sparing Rectal Cancer Surgery: A Long-term Longitudinal Follow-up. Dis Colon Rectum. 2019 Jan;62(1):14-20. doi: 10.1097/DCR.0000000000001228.
PubMed 30394987Battersby NJ, Bouliotis G, Emmertsen KJ, Juul T, Glynne-Jones R, Branagan G, Christensen P, Laurberg S, Moran BJ; UK and Danish LARS Study Groups. Development and external validation of a nomogram and online tool to predict bowel dysfunction following restorative rectal cancer resection: the POLARS score. Gut. 2018 Apr;67(4):688-696. doi: 10.1136/gutjnl-2016-312695. Epub 2017 Jan 23.
PubMed 28115491Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, Palmer GJ, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum. 2014 May;57(5):585-91. doi: 10.1097/DCR.0000000000000116.
PubMed 24819098Juul T, Ahlberg M, Biondo S, Emmertsen KJ, Espin E, Jimenez LM, Matzel KE, Palmer G, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. International validation of the low anterior resection syndrome score. Ann Surg. 2014 Apr;259(4):728-34. doi: 10.1097/SLA.0b013e31828fac0b.
PubMed 23598379Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
PubMed 22504191Juul T, Elfeki H, Christensen P, Laurberg S, Emmertsen KJ, Bager P. Normative Data for the Low Anterior Resection Syndrome Score (LARS Score). Ann Surg. 2019 Jun;269(6):1124-1128. doi: 10.1097/SLA.0000000000002750.
PubMed 31082911Eid Y, Bouvier V, Dejardin O, Menahem B, Chaillot F, Chene Y, Dutheil JJ, Juul T, Morello R, Alves A. 'French LARS score': validation of the French version of the low anterior resection syndrome (LARS) score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients: a study protocol. BMJ Open. 2020 Mar 8;10(3):e034251. doi: 10.1136/bmjopen-2019-034251.
PubMed 32152168
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Low Anterior Resection Syndrome (LARS) Score for Measuring Bowel Dysfunction After Sphincter-preserving Surgery Among Rectal Cancer Patients
- ClinicalTrials.gov ID
- NCT03569488
- Acronym / sponsor ID
- LARS / 17-247
- Conditions
- Rectal Cancer Patients
- Keywords
- quality of life, sphincter-sparing surgery, LARS score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, French Research Group of Rectal Cancer Surgery (GRECCAR), Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oncological rectal cancer outcomes have improved considerably because of optimal surgery by total mesorectal excision in conjunction with multidisciplinary team management by selective multimodal therapy (ie, neo-adjuvant chemo-radiotherapy). The 5-year survival has increased to more than 50% and local recurrence has been reduced to less than 10%. These advancements have resulted in more patient receiving sphincter-preserving surgery (SPS). With an increasing number of rectal cancer survivors, the investigators observe a rising attention to the disordered bowel function after SPS, called "low anterior resection syndrome" (LARS). LARS appear immediately after surgery, becoming most pronounced during the first few months, and improved thereafter, reaching a steady state after around two years. However, up to 60% of patients with SPS suffer from LARS which impaired their quality of life (QoL). The prevalence and severity of LARS is difficult to assess due to heterogeneity of the assessment tools. A group of Danish authors have recently developed and validated a five-item instruments for evaluation of LARS (LARS score). It represents to date the best questionnaire to capture anorectal postoperative function and consists of five items: incontinence for flatus, incontinence for liquid stool, frequency of bowel movements, clustering of stools, and urgency. It allows a categorization of patients into 3 groups: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). Developed in Danish, it is now internationally validated with translations in Chinese, English, German, Spanish and Swedish. To our knowledge, French version of the LARS score is not yet available. The aim of our study will be to adapt the LARS scale questionnaire to the French language (LARS-F), and assess its psychometric properties.
Inclusion criteria will be patients 18 years old or above who were operated for rectal cancer from 2007 to 2015. Exclusion criteria will include the presence of stoma and/or known disseminated or recurrent disease. Patients will be identified through local databases by the local investigators at each of the participating centers with a minimum duration of 24 months after surgery to allow their bowel function to have regained stability. This study will be supported by the French Research Group of Rectal Cancer Surgery in order to allow the feasibility of the project.
After translation/back-translation procedures in accordance with the permission from the original authors, the LARS-F score and the whole translation process will be then sent to the original authors for approval. Then a pilot study will be conducted. The French questionnaire (LARS-F score) will be then administered to 100 patients in order to verify the adequacy and degree of comprehension of the questions. Reproducibility will be investigated by a test-retest procedure. A randomly selected subgroup of participants (n= 400) will be sent the LARS-F score questionnaire twice (with an interval of two weeks). The test-retest reliability of the questionnaire will be assessed by the Cohen's Kappa (no, minor and major LARS scores) or by intra-class correlation coefficient, ICC (quantitative LARS score). Then, eligible patients will receive a postal invitation to complete the LARS-F score and the l'European Organization for Research and treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29, respectively. The validity of the LARS-F score will be tested by using the indicators of convergent validity and discriminant validity. The convergent validity will be determined notably in this study by computing the correlations between the LARS-F score and the EORTC QLQ-C30 and QLQ-CR29 domains. For discriminant validity testing, the investigators will use known variables to affect bowel function after SPS, such as gender, age, neo-adjuvant radiation therapy, distance of the tumor from the anal verge, prior temporary stoma, and length of postoperative period.
The validation of the French version of the LARS score will allow to use a scientific instrument in order to assess both prevalence and severity of LARS. This instrument will allow to develop a future research and clinical practice in France. It will be used in the daily clinical practice to identify patients with LARS score. It will hopefully lead to improve the awareness of clinicians, in order to improve the prevention and the treatment of bowel dysfunction, as well as the information given to patients. In the future, the investigators will able to develop a new patient-led follow-up program based on symptom burden and health-related QoL.
Detailed description
Inclusion Criteria:
- Age between 18 and 80 years
- Rectal cancer patients undergoing curative sphincter-preserving surgery with partial or total mesorectal excision
- Surgery performed between January 2007 to January 2016, with reversal of the defunctioning stoma before January 2016;
- Hence all patients had had bowel continuity restored for at least 24 months Voluntarily participated in the study
Exclusion Criteria:
- The presence of stoma and/or known disseminated or recurrent disease
- Other diseases of bowel dysfunction (Crohn's disease)
- Cognition and/or language issues.
Detailed description of the implemented techniques
-The validation study of the French version of the LARS score is based on one hand on the face and content validities and on the other hand on the measurement of its psychometric properties in compliance with the standards published by American Educational Research Association \& al.
Outcomes measures
- After translation/back-translation procedures in accordance with the permission from the original authors, the LARS-F score and the whole translation process will be then sent to the original authors for approval. Then, eligible patients will receive a postal invitation to complete the LARS-F score and the l'European Organization for Research and treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29, respectively. For each item, ceiling and floor effects will be sought.
- The reliability will be assessed by both internal consistency (Cronbach's alpha coefficient).
- To evaluate reproducibility, a test-retest study will be performed in a randomly selected subgroup patients by comparing LARS-F scores obtained between the patient's first and second postal invitation (in an interval of 7-14 days).
- The correlations between the LARS-F score and the EORTC QLQ-C30 and QLQ-CR29 domains will allow to determine convergent validity. For discriminant and divergent validities testing, we will hypothesize that the LARS score will differentiate between the bowel functions of patients with different demographic or clinical features such as sex, age, length of postoperative period, distance of the tumor from the anal verge, radiation therapy, and prior temporary stoma.
- Sensitivity and specificity for minor and major LARS scores will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colorectal cancer
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- Rectal cancer patients undergoing curative sphincter-preserving surgery with partial or total mesorectal excision
- Surgery performed between January 2007 to January 2016, with reversal of the defunctioning stoma before January 2016;
- Hence all patients had had bowel continuity restored for at least 24 months Voluntarily participated in the study
Key exclusion criteria (3 listed)
- The presence of stoma and/or known disseminated or recurrent disease
- Other diseases of bowel dysfunction (Crohn's disease)
- Cognition and/or language issues.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT-LARS questionnaireFT-LARS questionnaire | Diagnostic test | – |
Primary outcome
validation of the French version of the LARS score
Time frame: baseline
* Cross cultural adaptation * Reliability : * Test-retest * Internal consistency * Face validity and content validity * Floor effect - Ceiling effect * Discriminant validity * Convergent validity and Divergent validity * Known-group method and relationship between each item and subscales
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 30126800Sarcher T, Dupont B, Alves A, Menahem B. Anterior resection syndrome: What should we tell practitioners and patients in 2018? J Visc Surg. 2018 Oct;155(5):383-391. doi: 10.1016/j.jviscsurg.2018.03.006. Epub 2018 Aug 17.
- Background: PubMed 28161008Abdelli A, Tillou X, Alves A, Menahem B. Genito-urinary sequelae after carcinological rectal resection: What to tell patients in 2017. J Visc Surg. 2017 Apr;154(2):93-104. doi: 10.1016/j.jviscsurg.2016.10.002. Epub 2017 Feb 1.
- Background: PubMed 28601342Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.
- Background: PubMed 27801543Lakkis Z, Manceau G, Bridoux V, Brouquet A, Kirzin S, Maggiori L, de Chaisemartin C, Lefevre JH, Panis Y; French Research Group of Rectal Cancer Surgery (GRECCAR) and the French National Society of Coloproctology (SNFCP). Management of rectal cancer: the 2016 French guidelines. Colorectal Dis. 2017 Feb;19(2):115-122. doi: 10.1111/codi.13550.
- Background: PubMed 30394987Pieniowski EHA, Palmer GJ, Juul T, Lagergren P, Johar A, Emmertsen KJ, Nordenvall C, Abraham-Nordling M. Low Anterior Resection Syndrome and Quality of Life After Sphincter-Sparing Rectal Cancer Surgery: A Long-term Longitudinal Follow-up. Dis Colon Rectum. 2019 Jan;62(1):14-20. doi: 10.1097/DCR.0000000000001228.
- Background: PubMed 28115491Battersby NJ, Bouliotis G, Emmertsen KJ, Juul T, Glynne-Jones R, Branagan G, Christensen P, Laurberg S, Moran BJ; UK and Danish LARS Study Groups. Development and external validation of a nomogram and online tool to predict bowel dysfunction following restorative rectal cancer resection: the POLARS score. Gut. 2018 Apr;67(4):688-696. doi: 10.1136/gutjnl-2016-312695. Epub 2017 Jan 23.
- Background: PubMed 24819098Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, Palmer GJ, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum. 2014 May;57(5):585-91. doi: 10.1097/DCR.0000000000000116.
- Background: PubMed 23598379Juul T, Ahlberg M, Biondo S, Emmertsen KJ, Espin E, Jimenez LM, Matzel KE, Palmer G, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. International validation of the low anterior resection syndrome score. Ann Surg. 2014 Apr;259(4):728-34. doi: 10.1097/SLA.0b013e31828fac0b.
- Background: PubMed 22504191Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
- Background: PubMed 31082911Juul T, Elfeki H, Christensen P, Laurberg S, Emmertsen KJ, Bager P. Normative Data for the Low Anterior Resection Syndrome Score (LARS Score). Ann Surg. 2019 Jun;269(6):1124-1128. doi: 10.1097/SLA.0000000000002750.
- Derived from this study: PubMed 32152168Eid Y, Bouvier V, Dejardin O, Menahem B, Chaillot F, Chene Y, Dutheil JJ, Juul T, Morello R, Alves A. 'French LARS score': validation of the French version of the low anterior resection syndrome (LARS) score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients: a study protocol. BMJ Open. 2020 Mar 8;10(3):e034251. doi: 10.1136/bmjopen-2019-034251.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer Patients, run by University Hospital, Caen at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validation of the French version of the LARS score (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569488, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.